Health product recall

ADVIA DIFF TIMEpac 120, 2120i, 2120 (2019-06-28)

Starting date:
June 28, 2019
Posting date:
July 15, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70419

Last updated: 2019-07-15

Affected Products

A. ADVIA 120 DIFF TIMEpac
B. ADVIA 2120i DIFF TIMEpac
C. ADVIA 2120 DIFF TIMEpac

Reason

Siemens Healthcare Diagnostics has confirmed that platelet clump flags (PLT-CLM) may be generated in the perox channel of the ADVIA 120/2120/2120i Hematology System while running CBC/DIFF (complete blood count / differential) whole blood samples with DIFF TIMEpac reagent lot numbers 94414, 94415 and 31129, in samples without platelet clumps. ADVIA 120/2120/2120i DIFF TIMEpac lot numbers 94414, 94415 and 31129 contain perox 1 reagent lot 94412. The accuracy of the platelet results is not impacted when the perox 1 reagent (lot number 94412) is used on the system and a PLT-CLM flag may be generated due to this issue. Additionally, platelet results are reported from the red blood cell/platelet (RBC/PLT) channel and not measured in the perox channel where platelet clumps are detected. However, the platelet results will be flagged if the clump count is greater than 300, directing the user to investigate the sample.

Affected products

A. ADVIA 120 DIFF TIMEpac

Lot or serial number

94414

Model or catalog number

10312270

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES

B. ADVIA 2120i DIFF TIMEpac

Lot or serial number

31129

Model or catalog number

10312270

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES

C. ADVIA 2120 DIFF TIMEpac

Lot or serial number

94415

Model or catalog number

10312270

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES